NCT06929923

Pro-2-Cool Pivotal Trial II

An Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: TecTraum Inc. · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

Detailed description

This is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to a total of 72 patients (approximately 36 patients in the treatment arm and 36 patients in the control arm) following sports-related, mTBI.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Pro-2-Cool Device	The Pro-2-Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-04-16
• Last updated: 2025-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study